FDA Rules for Pharmaceutical Analytical Method Validation

FDA Current Good Manufacturing Practice requirements include that validation of non-compendial analytical methods and the verification of compendial methods. The various aspects of validation or verification will be discussed, including the order in which they should be conducted and establishing specifications for success.

Why You Should Attend:

All chemists involved in the development and validation of analytical methods, those who supervise them and those who review or submit their method validation reports must know about the FDA rules for method validation. Defects or absence of validation or verification of analytical methods are frequent observations of FDA application reviewers and deficiencies during FDA inspections. Learning how to minimize these problems is highly recommended.

Areas Covered in the Session :

  • General Information
  • Specificity
  • Accuracy
  • Precision
  • Sensitivity
  • Linearity
  • Range
  • Robustness
  • Reproducibility
Who Should Attend:

  • Analytical Method Development Supervisors
  • Analytical Method Validation Supervisors
  • Method Research Chemist
  • Analytical Chemists
  • QC and R&D Laboratory Supervisors
  • Regulatory Affairs Supervisors

FDB2952

Dr. Loren Gelber

Dr. Loren Gelber has more than 40 years of experience in pharmaceutical industry regulatory compliance. She worked for about 10 years at the FDA, including as a reviewer in the Division of Generic Drugs. She then transitioned to industry, working for four different pharmaceutical companies. For the last 13 years she has been a regulatory compliance consultant, both for consulting companies and independently.

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  • Presentation Handout in .pdf format
  • Presentation from the Speaker
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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance